Trial Review

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Interventions for replacing missing teeth: single oral implants placed into fresh extraction sockets or early or completely healed sockets (immediate, early and delayed placement) to support single implant crowns for 5 years

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Secondary ID [1]2624750

there isn't a secondary ID for this trial

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Universal Trial Number (UTN)

There is no UTN

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Trial acronym

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Linked study record

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Health condition

Health condition(s) or problem(s) studied:

Single tooth loss38170

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Condition category

Condition code

Oral and Gastrointestinal3999399900

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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

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Intervention/exposure

Study type

Interventional

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Description of intervention(s) / exposure

Placement of single endosseous wide diameter titanium oral implants in the fresh extraction sockets or early healed sockets (3-5 weeks) in the molar region to support single implant crowns for 5 years. Surgical technique: Atraumatic extraction, sectioning of the molars and removal of each root individually. Sockets will be prepared with standard drills and tapered osteotomes to prepare the interradicular bone.

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Intervention code [1]35360

Treatment: Devices

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Comparator / control treatment

Placement of single endosseous wide diameter titanium oral implants after complete bone healing (at least 4 months post-extraction) in the molar region.Same type of implants will be used in both test and control groups.

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Control group

Active

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Outcomes

Primary outcome [1]49030

To evaluate the success rates of single wide-diameter implants placed at different times following extraction of molar teeth. The success criteria of Zarb and Albrektsson (1998) and prosthodontic success criteria of Walton (1998) will be used.

Procedure for enrolling a subject and allocating the treatment (allocation concealment
procedures)

Not applicable

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Methods used to generate the sequence in which subjects will be randomised (sequence
generation)

Not applicable

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Masking / blinding

Open (masking not used)

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Who is / are masked / blinded?

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Intervention assignment

Parallel

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Other design features

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Phase

Not Applicable

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Type of endpoint(s)

Efficacy

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Statistical methods / analysis

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Recruitment

Recruitment status

Active, not recruiting

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Date of first participant enrolment

Anticipated

12/11/2008

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Actual

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Date of last participant enrolment

Anticipated

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Actual

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Date of last data collection

Anticipated

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Actual

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Sample size

Target

39

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Accrual to date

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Final

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Recruitment outside Australia

Country [1]12590

New Zealand

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State/province [1]12590

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Funding & Sponsors

Funding source category [1]39980

Commercial sector/Industry

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Name [1]39980

Southern Implants

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Address [1]39980

1 Albert Road Irene 0062

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Country [1]39980

South Africa

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Primary sponsor type

Commercial sector/Industry

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Name

Southern Implants

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Address

1 Albert Road Irene 0062

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Country

South Africa

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Secondary sponsor category [1]36550

None

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Name [1]36550

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Address [1]36550

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Country [1]36550

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Ethics approval

Ethics application status

Approved

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Ethics committee name [1]60750

Lower South Regional Ethics Committee

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Ethics committee address [1]60750

229 Moray Place Ministry of HealthPO Box 5849Dunedin

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Ethics committee country [1]60750

New Zealand

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Date submitted for ethics approval [1]60750

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Approval date [1]60750

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Ethics approval number [1]60750

LRS/08/08/034

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Summary

Brief summary

Objectives: To evaluate the clinical outcomes, peri-implant parameters, microbial environment and success rates of three different placement times of single wide implants for replacing molar teeth. Materials and mehtods:Wide –diameter implants will be placed at different times following extraction of a single molar tooth in either mandibular or maxillary arches. A total of 39 participants will be randomly allocated to three equal sized groups (13 per group), a control and one of the test groups as follows: Control group: Implants placed after complete bone healing Test group 1: Implants immediately place after extraction Test group II: Implants placed after an early osseous healing time (3-5 weeks).

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Trial website

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Trial related presentations / publications

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Public notes

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Contacts

Principal investigator

Name
290270

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Address
290270

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Country
290270

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Phone
290270

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Fax
290270

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Email
290270

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Contact person for public queries

Name
121840

Dr Warwick Duncan

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Address
121840

Oral Implantology Research Group Sir John Walsh Research InstituteSchool of Dentistry University of OtagoP.O Box 647 Dunedin 9054

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Country
121840

New Zealand

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Phone
121840

+64 3 479 7110

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Fax
121840

+64 3 479 5079

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Email
121840

warwick.duncan@otago.ac.nz

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Contact person for scientific queries

Name
31120

Dr Warwick Duncan

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Address
31120

Oral Implantology Research Group Sir John Walsh Research InstituteSchool of Dentistry University of OtagoP.O Box 647 Dunedin 9054